Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial

Trials

Study Protocol

Pieter Jan F. de Jonge¹  Marco J. Bruno¹  Florence E. M. de Rijk²  Jeanin E. van Hooft³  Erwin J. M. van Geenen⁴  Robert C. Verdonk⁵  Charlotte L. van Veldhuisen⁶  Marc G. Besselink⁷  Hjalmar C. van Santvoort⁸  Cornelis H. van Werkhoven⁹ 

[1] Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands;Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands;Department of Research and Development, St. Antonius Hospital, Nieuwegein, The Netherlands;Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands;Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands;Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands;Department of Research and Development, St. Antonius Hospital, Nieuwegein, The Netherlands;Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, The Netherlands;Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands;Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, The Netherlands;Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands;Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands;Department of Surgery, University Medical Center Utrecht, Utrecht, The Netherlands;Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands;

关键词: Chronic pancreatitis;    Management algorithm;    Integrated care;    Evidence-based;    Quality of life;    Pain severity;    Stepped-wedge;    Randomized controlled trial;    COMBO;   

DOI  :  10.1186/s13063-022-07044-8

 received in 2022-06-02, accepted in 2022-12-19,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundChronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP.MethodsThe COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial.DiscussionThis is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice.Trial registrationISRCTN, ISRCTN13042622. Registered on 5 September 2020.

【 授权许可】

CC BY   
© The Author(s) 2023

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Fig. 6

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